Topic 38 – FDA Comments on Off-label Dissemination – Did it just tip its hand on upcoming off-label policy?

Have you had the opportunity to follow the Amarin lawsuit against the FDA?  If not, a quick recap:  

Amarin is literally a fish-oil salesman – they have fish-oil pills that are already FDA approved for the treatment of very high levels of triglycerides.  They had conducted clinical trials to expand their label to patients with lower levels of high triglycerides.  The FDA rejected their application.  Amarin decided it wanted to share the results of those studies anyway since they were positive and sued the FDA for the right to share its data on off-label use.

The interesting part comes from the FDA response letter.  Putting aside their primary concern that Amarin failed to work with them before suing them, the letter signed by Janet Woodcock went on to layout the condition in which Amarin (or for that matter any pharam company) can share off-label data.

First, the letter reiterated what we already know and have discussed: the reprint exemption to off label communication – distribute reprints from peer-reviewed journals, avoid some simple issues like highlighting only the “good” passages, and you are in the clear.

But then the letter goes on to say that Amarin can also write up and distribute its own summary of the results of their trial if the write up:

• Remains factual and does not omit material information or introduce bias
• Includes full data for each treatment group
• States that the current label does not approve of the use
• States that the impact on the off-label use has not been determined
• Shares data about other, known similar studies that may have different results
• Any financial or affiliation biases between the firm and the people who conducted the study

They go on to add that to protect against being misleading the company should:

• Provide a copy of the current Package Insert
• Provide a copy of any relevant reprints
• Discuss these topics in an educational or scientific setting and not as a part of a promotional discussion or attached to promotional materials
• Discussions should be conducted by persons with the appropriate background or training to accurately communicate scientific information

While that is still a lot of hurdles, that is a long way from reprints only.  And while these are NOT an official policy now, I think this is telegraphing what we should expect to see in the upcoming policies.

I particularly like the final bullet point which makes it clear that these topics need to be discussed by roles that sound very much like MSLs. 

To speculate, if the FDA were to allow establish this as the policy, it would surely free up MA to proactively share both off label and label supportive information.  That would be a big improvement for some MA organizations that deny all proactive sharing of off-label information.

You can find the letter HERE.  The juicy bits begin on page 8.

What do you think?  Click here to leave a comment.

Topic 36 - Off-Label Promotion Prosecution is Changing – and Medical Affairs Should Benefit

Normal disclaimer: I am not a lawyer just a lay observer.

I was at the 3^rd Annual World Congress Summit on the Evolving Role of Medical Affairs.  As in the last two years, one of the highlights is the presentation by a representative of the OIG and US States Attorney on Off-Label Promotion.

Usually this is an opportunity for them to remind us that pharma is not allowed to promote off label, trot out examples of people who were prosecuted for off-label promotions (which are almost exclusively Sales and Marketing examples, not MA examples) and then encourage us to snitch on our organizations if we think we see this behavior.

 

But this year was different.  This year we were all introduced to an important new term – Off-label Plus.  What does Off-label Plus mean?  It’s how they refer to cases that they are willing to prosecute.  In light of the Caronia ruling (an overview of which you can find here, with subsequent commentary here and here), they are no longer willing to base cases on simply promoting off label (assuming the test laid out in Caronia that the off-label information presented is from a credible, unbiased source, like a “real” journal, and the presentation is not misleading).  Instead, they are only willing to go after cases where there is Off-Label Plus something else, like Kickbacks or Fraud of some type. 

In my opinion this is huge for medical affairs – most medical affairs organizations are unwilling to proactively share even an article published in the NEJM if it is off-label out of fear of being accused of promoting off-label.  Instead we wait to be asked, since responding to a question is not promotion.  I think the fear of promotion is now unjustified.

The simple reality is that even before Caronia no medical affairs employee has ever been prosecuted for simply providing accurate, non-misleading off-label information.  Caronia  was a sales guy, not medical affairs. The only example that the prosecutor could cite of an MA employee being prosecuted was a device company where the medical affairs lead used speaking fees as a kick backs.   Now that Caronia is out there, I think the risk is even lower. 

Just like our treatments, all of medical affairs is a risk / benefit.  If we wanted zero risk, we would not have medical affairs or sales or marketing for that matter.  Instead we reduce our risks through the use of strong processes and a compliance function to ensure those processes remain in place.  It is my assertion that providing credible, non-misleading peer-reviewed published off-label data pro-actively is no longer a major risk, assuming there are procedures in place to avoid all the other “Plus” activities. 

I don’t expect this to change overnight, but some organizations are going to start operating this way and when the sky does not fall, all medical affairs organizations will be operating this way – my guess is within 5 years.  And this is all for the best – its good for HCPs because they will have the latest information, its good for patients because their HCPs will be well informed and its good for medical affairs because it allows us to do our jobs even better than today.

What do you think?  Leave a comment by clicking here.

Topic 32: Big Data in MA – Revisited

Overview

A couple of years ago I wrote a post (check it out here) on the emergence of big data for Medical Affairs. Given the rapid evolution of big data, two years is a long time ago so it’s worth revisiting this topic.

Let’s recap what we mean by “big data.” It is a broad concept, but for our discussion today we will be using big data to refer to the new capability to pull together huge quantities of data that were not directly generated for the purpose they are now being applied. Biopharma has excelled at generating proprietary data sets for a specific purpose, but big data take advantage of non-proprietary data that was generated for a different purpose by applying it in a new way.
These external data sources range in structure, format and value. The real trick to big data is pulling the data from disparate sources, efficiently cleaning it and standardizing it to allow it to be cross-referenced, then finding novel ways to use it.

Example of Big Data in MA

In the last couple of years we have seen examples of companies set up to provide big data services to MA. I will single out one here as an example, but this is not intended as an endorsement. I have no relationship with this company or practical experience with their products.

The company, Med’meme, is a case study of big data in MA. Based on their website, Med’meme takes large, public data sets – in this case lists of scientific presentations from medical meetings and peer-reviewed journals and clinical trial information at least – and in their backroom they apparently standardize it to make all those data cross referenceable. How well they do this, how complete and how accurate the data is, I can’t say. But, when you think about that data source as an MA professional I am sure you are jumping to a bunch of potential uses - like the ability to rank KOLs, to identify new KOLs, to track TA trends in publishing, to identify potential investigators, to be alerted to new publication identification, etc.

And that is the beauty of big data – there does not appear to be anything in their data set that has not been available (with some costs) to biopharma for years. Their service is finding a way to scrape it all together, standardize it and allow it to be searched effectively.

Buy v Build in Big Data

When I first published the article about big data I had a number of “buy vs. build” questions. The reality of big data in its current form is about re-using publically available data in novel ways, so building it internally is unlikely to produce proprietary value. However, combining these data sets with proprietary data, or asking interesting and unique questions of the data is something that can remain proprietary – so some hybrid solutions may be valuable.

If big data is not a part of the MA information technology planning it should be.  This capability represents an opportunity for strategic advantage in the short-term until it is widely adopted.

Conclusion

Big data is a new reality. A huge new data set, the Sunshine Act database, has just come on-line, and other data sources are increasingly making their data available for these types of analysis. Expect to see major development in this area in the coming couple of years.

What has been your experience with big data in MA? Leave a comment.

Topic 31: Changing Relationship between Medical Affairs and Access and Reimbursement

Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.

Introduction

I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.

AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations and co-payments for the patients. Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.

Defining a New Relationship

Just as the pressures on AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.

However, now that AR’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between AR and MA is changing.

For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific needs:

1. The formulary committee needs a more robust scientific understanding of the drug’s properties, its known efficacy, its known risks and its place in the overall therapeutic area’s treatment options


2. The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) data like cost effectiveness and total cost of care, and comparator data to allow them to understand the full impact of the drug’s use

Both of these ramped up requirements have direct impact on MA’s relationship with AR.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for P&T Committee presentations is growing from a part of the presentation to the core of the presentation. And with that growth comes the need for greater specialization by the presenters.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:

1. Much greater degree of training for Field Medical on the role of AR and P&T Committees
   OR


2. The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR

Given the importance of AR, supporting their needs can no longer be seen by MA as a side responsibility. Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.

More Specialized Data

In many organizations, MA has taken the lead in developing data post-approval. And while HEOR has always been a part of generating that post-approval data, its importance has grown significantly. The increased demand for HEOR data has a number of implications:

• HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets


• Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study efforts, must give greater consideration to the HEOR needs


• The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase


• The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed


• Processes for ensuring that the input of AR is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees

In some companies have decided that HEOR is so important to AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees are addressed has become a major priority for post-approval research.

Closing Thoughts

MA’s role as the owner of scientific education and communication for post-approval drugs is a critical element in today’s formulary-driven environment. MA needs to be an active partner to AR as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / AR partnership? Leave your comments below.

If you have a topic you would like me to cover, please email me from the link to the right.

Topic 28: Big Data and Medical Affairs

“The era of Big Data is here!”  That may be true but what does that mean for Medical Affairs?  As in all of biopharma, MA is comfortable working with data.  So much of our work revolves around discussing data and the implications of data that many people may think that we were already living in the era of Big Data.

But for most MA organizations, the data sets we have focused on are purpose generated - either our own data or data from similarly-scaled studies conducted by others.  Big Data refers to something different.  I like the differentiation that SAS uses when comparing Big Data to the past data sets.  They break it down to four “V”s and a C:

• Volume: Hugely increased data volume from the past


• Variety: Since the data is produced in many different ways, it has many different formats and structures


• Velocity: Both how fast the data is being produced and how fast it must be processed


• Variability: Inconsistent data flows, with peaks and valleys


• Complexity: Driving value out of these data sets is highly complex and difficult

This is not your grandfather’s data sets.  What are some examples of Big Data as relevant to biopharma and MA:

• Electronic Health Records data from a variety of sources


• Search engine data (see an example of analyzing search data to find safety signals here)


• Sunshine Act Physician Spend Data (when it becomes available)


• Social media data


• Competitors clinical trial data as it is released

Contained within these and many Big Data sources are key tools for MA:

• Valuable therapeutic information


• Unique customer insights


• KOL identification and information


• Visibility of competitors drug development and support efforts


• Important drug safety signals

But, none of these benefits can be achieved unless the question is asked and the data is analyzed.  I would suggest that effective MA organizations of the future will need to have the capacity to ask and answer these types of questions.

In order to do so, MA organizations will either need to build or have access to increased levels of biostatistical and epidemiological resources.  And these resources need to have skills directly related to Big Data.  The characteristics that differentiate Big Data from existing data sets also means that many existing biostats and epi staff do not have the expertise or confidence working with these large, external data sets.  MA organizations need to ensure that people with exactly these skills sets are available within their organizations or from outside vendors and that these resources have the capacity to support MA.

Then, MA needs to improve its overall level of confidence defining Big Data questions, conducting Big Data analysis, and discussing the results with others.  Given the difference in the source of this type of data, the way this data is presented and discussed must be different too.  Everyone in MA, but especially the MSLs, must become more comfortable understanding the nuance of this type of data analysis and discussing both the strengths and weaknesses of working with Big Data.

The era of Big Data is here.  MA has a long history of effectively using data and explaining data in support of its organization.  MA leaders must investigate and embrace Big Data to take advantage of all the tools available today.  The questions unasked are always the questions unanswered.

What is your experience with Big Data?  Please leave a comment.

Topic 26: Highlights of Day 3 of the Medical and Scientific Communications 2013 Forum

­

The final half day for the MSC meeting had an excellent and well received discussion about MSL metrics.  I also attended an interesting talk on coordinating global publications.  My take on it below

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  Metrics

• Must vary as focus of the organizations varies
  
  
  
  • Plays back to earlier comments about staying focused if you want to see improvement over time
  
  
  • Mix of Activity, Value and Compliance measures are needed
  
  
  • IIS Metrics
    
    
    
    • Good to track in terms of just a sense of the program
    
    
    • NO goals should be put in place
    
    
    • Additional metrics discussed
      
      
      
      • Engagement with ACOs or Cancer Networks or other new healthcare entities
      
      
      • Congress attendance valued by quality metric of the outputs not the activity
      
      
      • Dollars saved by asking MA to assist CD, especially when CD has a bid from a vendor to provide the same service
      
      
      • Internal stakeholder feedback
        
        
        
        • Important – best to solicit directly via email/conversation
        
        
        • BE CAREFUL – some organizations do not allow feedback from Commercial
        
        
        
        
      
      
      
      
    
    
    
    
  
  
  
  

-  Reports/Dashboards/Scorecards

• Need to develop different outputs for different stakeholders


• What is needed internally at MA is not what you want to focus on with other internal stakeholders


• Always pair summarized numbers with text explaining value and highlighting accomplishments/learnings

-  MA IT Systems

• As mentioned earlier, a number of companies seem to be moving toward the Veeva Platform which is built on top of Salesforce.com CRM.
  
  
  
  • Veeva seems to be driven by the commercial side, but it has MA capabilities
  
  
  • Some people mentioned that you need to be careful about Veeva training and documentation as it often defaults to commercial language
  
  
  • Some organizations use it to track not only KOL interactions but also time spent in the office doing various projects
  
  
  • Focus on time tracking seemed to be for internal management not for external publication
  
  
  
  

-  Global Publication Coordination

• Increasingly important to have global plan


• Much easier to manage when Pub Team gets involved earlier in the development cycle


• MA on Pub Team should work as a facilitator for Pub Team’s interaction with other functions given their central role


• Press release management globally remains a major challenge
  
  
  
  • General consensus that prior to first presentation at a meeting, press release should be simply binary – met endpoints, did not meet
  
  
  • Too much data in press release can tick off journals threatening publication
  
  
  
  

-  Odds and Ends Ideas

• Heard from a number of different companies that MSL groups focused on payer support in the US need to be between 6 and 10 in size to cover all the needs – not scientific but an interesting convergence


• MSLs at clinical study initiation visits:
  
  
  
  • Good idea BUT has GCP implications
  
  
  • Need to hammer out how MSLs can fit within CD’s SOPs with ClinOps before engaging
  
  
  • May ultimately require update to CD’s SOPs
  
  
  
  

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

If you were at the meeting and have other thoughts please leave them in the comments.

Topic 25: Highlights of Day 2 of the Medical and Scientific Communications 2013 Forum

A great second day for the MSC meeting, with a range of interesting topics.  My take below.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  MSL Value Proposition:

• Questions of value are often linked with a lack of fully understanding what a modern MSL does, vs. MSLs of old


• Many in group have had good success inviting key stakeholders, up to and including CEO, for ride-alongs with MSL
  
  
  
  • Proven track record at overcoming skeptics about MSL skills and value
  
  
  • One key to proving value is remain consistent in priorities to show value over time
    
    
    
    • When priorities are shifting its hard to build up track record
    
    
    • Remember that one of the greatest MSL values, relationships, is the least structured and always make that point clear
    
    
    
    
  
  
  
  

-  Other non-traditional areas where MSLs can show value:

• Training CRAs on underlying science before trials


• Conducting formal evaluations of CME vendors to ensure vendors are providing good value


• Identifying authors for Pub group

-   Measure what matters to the people that matter

• Develop measures that highlight accomplishments that only MSLs can achieve


• Create monthly list of these unique accomplishments to address qualitative questions

-  External Surveys

• Important to get qualitative measures


• But expensive and difficult


• Also, expect lots of push back from people who don’t think they are fair


• Don’t let the complainers win, the data is critical to effectively target efforts

-  A number of MSL organizations use monthly internal newsletters

• Highlight key activities and accomplishments


• Provide some science training


• Implicitly defines values and culture through examples chosen and emphasis

-  Challenge of “boom bust” in MSL team sizing

• Number of speakers referred to the challenge of staffing for launch only to see the team significantly reduced 1 to 2 years after launch


• This is especially challenging outside of the US where country-level resources are very limited


• Need to consider this issue up-front during initial staffing and make the case for the long term from the start

-  Breakout session about MSL management

• Almost everyone in group had turnover of less than 10% and most less than 5%


• Most organizations had two non-managerial  levels of MSL – MSL and Sr. MSL
  
  
  
  • Some organizations had three with an Executive MSL above Sr.
  
  
  • Most organizations had at least two managerial levels but the titles varies
    
    
    
    • Some had three
    
    
    • Expectations about activity level varied but some examples from different companies:
      
      
      
      • 4 visits per week
      
      
      • X number of interactions per week (phone/email/visit)
      
      
      • MSLs will be out in the field 3 to 4 days per week
      
      
      • Key to expectations is flexibility
        
        
        
        • Some MSLs in small geogs some in large, their expectations should be different
        
        
        • Some TAs have large number of meetings, some few, so their expectations should be different
        
        
        
        
      
      
      
      
    
    
    
    
  
  
  
  

-  Mobile technology

• IPADS is the de-facto mobile tech of today


• Currently adjunct devices to laptops, NOT replacements


• Hard to justify on “cost saving” but easy to justify on WOW factor


• Be careful of SOPs that are linked into the old way of doing things, may need to be re-written to accommodate the tablet


• User experience is more important on Ipad than on PCs
  
  
  
  • Users have very low tolerance for clunky Ipad interfaces
  
  
  • Some other interesting ideas:
    
    
    
    • KOLs are likely to grab the Ipad so make sure everything you don’t want them to see is locked down
    
    
    • Ipad syncing is a manual process and may people may avoid, so build in lock outs to programs to force them to update at least monthly
    
    
    • 4 Digit standard Ipad passwords stink – they are breakable in minutes, use a much longer password
    
    
    • Use  cloud-based apps like DropBox or Google Drive only after being approved by compliance
    
    
    • People want to use their Ipads for personal stuff (photos, music, games) and most companies let them use it for that as well
    
    
    • Allow people choice in covers and other accessories since it is very personal
    
    
    • Have an accessories swap program to allow people to turn in accessories they no longer want and others can use
    
    
    
    
  
  
  
  

-  Odds and Ends Ideas

• Conduct “Office Hours” during major meetings when top CD resources are available in booth so MSLs can introduce their KOLs


• Compliance ride alongs – if compliance is unsure of an approach, offer to pilot it with them on a ride along so they can see it in action then make a determination


• Community MSL group focused on non-HCPs, like Advocacy Group

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

The meeting remains a very positive experience.  One of the key takeaways from today, however, was the desire of the audience to have more time to interact and learn from each other.  A good problem to have!